COVID-19 vaccines, access and the intellectual property war



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Right now, anyone talking about vaccine equality and equity of access must surely sound a little bothered. In the area of ​​COVID-19, traditional ownership instincts remain. Add to that the disparity in manufacturing, bureaucracy, and the bad taste of politics, and we’d all be treated to long drafts of cynicism.

The COVAX (COVID-19 Vaccines Global Access Facility) program, meant to be a leveling measure to ensure fair and cheap global access to vaccines, risks sounding like a ball of rhetoric. Co-led by Gavi, the Coalition for Epidemic Preparedness and Innovations (CEPI) and the World Health Organization (WHO), these collaborators seek to “accelerate the development and manufacture of COVID-19 vaccines, and ensure access fair and equitable for all countries in the world. ”The group’s goal is to deliver 2 billion doses by the end of 2021. Last month, the WTO reported that 130 countries, comprising 2.5 billion people, had not yet received a single dose.

The project encountered a big problem. Many countries are not prepared to play the game. If they do, they do it in two stages. WHO Senior Advisor Bryce Aylward fears that “some countries are still pursuing agreements that would jeopardize the supply of COVAX.” This lack of loyalty to the cause is also of concern to WHO Director-General Tedros Adhanom Ghebreyesus. “We cannot beat COVID without vaccine fairness. Our world will not recover quickly enough without equity in vaccines, that is clear. ”

A suggestion to address the problems of access to COVID-19 vaccines has been put forward by several states and international organizations. The WHO last Friday called for an agreement to waive intellectual property rights to vaccines. “If not now when?” asked Ghebreyesus.

In October 2020, India and South Africa submitted a proposal to waive “certain provisions of the TRIPS Agreement [Trade-Related Aspects of Intellectual Property Rights] agreement for the prevention, containment and treatment of COVID-19. The waiver would be granted to WTO members so that they would not have to apply or apply certain provisions of Part II of the TRIPS Agreement, namely section 1 (copyright and Related), 4 (industrial designs), 5 (patents) and 7 (protection of undisclosed information). The waiver would be in place for a period agreed to by the General Council and until widespread global vaccination has taken place, with the majority of the world’s population being immunized.

An information document on the proposal, written by Médecins Sans Frontières (MSF), simply confirms that the proposed waiver was specific, applicable only to COVID-19 and not to “all TRIPs obligations, nor does it suggest a waiver beyond that. of what is needed for COVID -19 prevention, containment and treatment. If the waiver was granted, patents would not be applied or granted on “all drugs, vaccines, diagnostics and other COVID-19 technologies, including masks and ventilators, for the duration of the pandemic.” Collaboration on research and development (R&D), manufacturing, scale-up and supply of COVID-19 tools could also take place.

During discussions held by WTO members at the TRIPS Council from October 15-16 last year, opponents nailed their colors to the mast. Australia, Brazil, Canada, EU, Japan, Norway, Switzerland, UK and US were either formally opposed or not supporting the measure. The world of the COVID-19 vaccine had been clearly delineated: the rich and the rest.

The justifications for such statements do not make a pretty reading. All focus on one essential theme: the importance of maintaining a rock-solid intellectual property system in the name of innovative practice. An EU spokesperson suggested somewhat speciously that no obvious link could be demonstrated between access to vaccines and intellectual property barriers. “There is no evidence that intellectual property rights in any way hinder access to drugs and technologies related to COVID-19.” The UK government decided to reverse the basket with its reasoning, stressing the importance of having strict intellectual property rules if access to new products to fight the pandemic were to be made available. WHO COVID-19 Solidarity Trial Chair John-Arne Røttingen insists that “intellectual property is the least of the barriers” to the facilities needed for production, knowledge and to infrastructure.

South Africa sought to respond to these allegations on October 16 at the TRIPS Council meeting and again at the November 20 Council meeting. Examples included manufacturers of therapeutic monoclonal antibodies, such as Regeneron and Eli Lilly, which had limited their capacity through bilateral agreements. More specifically on vaccines, South Africa could point out the fight between MSF and Pfizer in India over the pneumococcal vaccine, protected by a patent effectively blocking the development of alternatives.

As if further evidence is needed on the efforts of the pharmaceutical giants to freeze and stop both innovation and access in the field of vaccines with generous IP shields, we must look no further than the case. of SK Bioscience in South Korea. The company has been involved in a patent litigation with Pfizer to develop a pneumococcal conjugate vaccine (PVC) under the name Skypheumo. SK Bioscience lost the case as the Supreme Court ruled that it could not sell Skypheumo until 2026, when Pfizer’s compounding patent for Prevenar 13 expired.

Since WTO decisions tend to be made by consensus, the waiver proposal has been stuck in the diplomatic purgatory of the TRIPS Council. Requests from Chile, Australia and Canada for evidence that the waiver would increase vaccine manufacturing capacity and help alleviate shortages have not helped. Burcu Kilic, Research Director for Access to Medicines at Public Citizen sees a crass agenda unfolding. “What [high-income countries] hope they can discuss and drag the issue into the fact that everything will be fine by the summer. ”

The WTO General Council meeting earlier this month saw no change in attitude from high-income countries towards the South African and Indian proposal. Neither the US nor the EU even wanted to discuss it. What rather occupied the delegates was the proposal of the Director-General of the WTO, Ngozi Okonjo-Iweala, to seek a soft third-way alternative. This option would, according to Okonjo-Iweala, involve the granting of manufacturing licenses to countries guaranteeing “adequate supplies while ensuring that intellectual property issues are resolved”.

Before officially starting her role as Managing Director, she reiterated the idea that there was a way to increase access “by facilitating the transfer of technology under multilateral rules” and for the pharmaceutical giants to conclude. licensing agreements allowing other manufacturers to produce vaccines. Music, no doubt, to the representatives of Big Pharma.

To date, the ordered doses per capita, read as a comparison of states, seem striking. The US has 10.2 doses per person, the UK 7.6, the EU 6.5, and Australia 5. David Legge and Sun Kim, both of the People’s Health Movement, note that the African Union (AU), on the other hand, has agreements covering just 970 million doses for 1.34 billion people. Immunization coverage, at this stage, seems meager.

Some 115 members of the European Parliament issued a statement on February 24 calling on the European Commission and the European Council to reconsider their opposition to the proposed TRIPS waiver. Some EU member states and the European Commission had spoken of COVID-19 medical products “as global goods”, but there were no “actionable realities”. A waiver, members insisted, would not only remove heavy legal barriers to production, but would allow “the sharing of know-how and technology with GMP manufacturers in third countries.” The EU’s strategy, however, had been tribal, emphasizing domestic production with the potential to exacerbate “a dangerous North-South divide when it comes to affordable COVID-19 diagnostics, personal protective equipment, treatments and vaccines ”.

Vaccine loopholes suggest different timelines and differently filled pockets. Regions of the world are at risk of not being vaccinated, with infections and deaths expected to continue. Legge and Kim rightly see it as an abandonment of richer countries to chance, death and despair in favor of self-interest. If low- and middle-income countries were to wait another year or two of richer states “requisitioning vaccines, there will be around 40-50 million more cases of infections and possibly 2-3 million deaths. additional ”. Many of these mortality charts will be from health workers.

Dr Binoy Kampmark was a Commonwealth Fellow at Selwyn College, Cambridge. He teaches at RMIT University in Melbourne. E-mail: [email protected]



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